MacDx MACDX01

GUDID G506MACDX010

MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.

AMA Optics, Inc.

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• Primary Device ID: G506MACDX010
• NIH Device Record Key: 9ce8fc76-97c8-4266-a983-f8cf2d203e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MacDx
• Version Model Number: MACDX-01-PRO
• Catalog Number: MACDX01
• Company DUNS: 192827462
• Company Name: AMA Optics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G506MACDX010 [Primary]

FDA Product Code

• OUM: Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-11
• Device Publish Date: 2023-09-01

Devices Manufactured by AMA Optics, Inc.

• G506NC010 - NeuroColor: 2023-10-09 An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured pl
• G506BAM010 - AMA Optics Brightness Acuity Meter: 2023-09-11 A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.
• G506MACDX010 - MacDx: 2023-09-11MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
• G506MACDX010 - MacDx: 2023-09-11 MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
• G506PH010 - AMA Optics Panoramic Pinhole: 2023-09-11 An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.
• G506PHLC010 - AMA Optics Pinhole Clip: 2023-09-11 A lens chip having an optical lens and a pinhole disc with multiple apertures.
• G506PHLC020 - RAM Panoramic Pinhole Clip: 2023-09-11 A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo.
• G506RAM030 - AMA Optics Retinometer: 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture
• G506RAM040 - AMA Optics Retinometer: 2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture